The Electronic Patient Information Leaflet is the digital version of the traditional paper-based Patient Information Leaflet that accompanies packs of medicines. Unlike the more established electronic Clinical Outcomes Assessments (eCOA) or eConsent, electronic patient information has been slower to gain industry-wide and regulatory support. Patient Information feels like the poor relation. Electronic leaflets are designed to be more accessible, user-friendly, and interactive compared to their paper counterparts. They can be accessed via mobile devices, tablets, or computers, often through QR codes on medication packaging or healthcare apps.

Benefits of ePILs

The benefits of ePILs over paper PILs include:

• Better Accessibility: ePILs are accessible on digital devices, allowing users to read them anytime and anywhere. Font size and contrast can be adjusted to enhance readability according to individual preferences.

• Interactivity: ePILs can offer search functionality so that users can find relevant information quickly, such as dosage and side effects. Hyperlinks can link to external resources like educational videos or detailed explanations of medical terms and conditions. ePILs also enable the use of more detailed visual aids and interactive illustrations, especially useful for complex instructions, such as using an inhaler or injector.

• Multilingual Support: ePILs can be easily translated into multiple languages, enhancing accessibility for non-native English speakers. For example, a QR code could provide access to many languages, presented in digital text or text-to-speech audio.

• Regular Updating: Information can be updated more frequently than printed leaflets, ensuring patients receive the most current safety guidelines, contraindications, or dosage adjustments.

• Personalisation and Customisation: Content can be tailored based on the patient's profile, age, or medical history for more relevant information delivery. Interactive Dosage Calculators can provide personalised dosage recommendations, and lifestyle advice can be tailored to the individual.

• Emergency Contact Integration: The ePIL can offer quick links to emergency contacts, such as healthcare providers, the company itself, or the in-country equivalent of poison control centres.

Future Possibilities

ePILs are increasingly being integrated with wider digital health ecosystems, such as electronic health records (EHRs) and patient health apps, providing a cohesive healthcare experience. Opportunities offered by AI could lead to enhanced personalisation, delivering medical guidance based on the patient’s health history, medication interactions, and lifestyle. Additionally, integration with voice assistants like Siri, Alexa, or Google Assistant offers hands-free navigation, supporting users with low vision or physical disabilities.

Currently, there are examples of ePIL platforms and initiatives aimed at moving beyond paper leaflets. This includes the ePI Initiative from the EMA, promoting electronic patient information across the EU to improve accessibility and usability. In the US, the FDA is exploring digital labelling solutions to enhance patient engagement and safety. Within the pharmaceutical and medical device industries, companies are increasingly using QR codes on packaging to link to the latest ePILs, ensuring patients have access to up-to-date information.

Common Problems and Challenges with ePILs

Content

Even with the best ePIL capabilities, if the content is difficult to understand, the ePIL loses its value. Improving how pharmaceutical companies communicate with patients is as urgent as moving beyond paper PILs. Information overload is another challenge, where too much information can cause cognitive overload, reducing comprehension and leading to user abandonment.

Digital Accessibility and Usability

A digital divide exists due to factors like limited coverage in remote areas, affordability of devices, and varying digital literacy levels. Poorly designed interfaces or complex navigation can further limit access, highlighting the importance of iterative usability testing during design.
Technical issues, such as internet connectivity and compatibility with different devices or operating systems, can hinder ePIL usage. Inconsistencies in design, structure, and navigation across platforms also affect user experience.

Data Privacy Concerns

ePILs that require login or personal data input may raise privacy and security concerns. This is particularly relevant if ePILs are personalised using private data, such as electronic patient records. Questions arise about data ownership and potential unethical uses, such as monetisation. Regulatory oversight is crucial to address these concerns.

Regulatory Approval

ePILs need to comply with regulatory standards set by authorities such as the FDA, EMA, or local Competent Authorities. Regulations must be proactive, not reactive, to keep pace with fast-moving digital innovation. Otherwise, outdated and toothless regulations could lead to inconsistent ePIL quality, content, and presentation.

Conclusion

Electronic Patient Information Leaflets (ePILs) offer significant advantages over traditional paper leaflets, including enhanced accessibility, interactivity, multilingual support, and real-time updates. By integrating with digital health systems and leveraging AI, ePILs have the potential to provide a more personalised and user-friendly experience. However, challenges such as content clarity, digital accessibility, data privacy, and regulatory compliance must be addressed for successful implementation. As the industry continues to innovate, effective regulation and user-focused design will be crucial to fully realising the potential of ePILs.

Thank you for reading!

Mark Gibson

Leeds, United Kingdom, February 2025

References:

Diamant JD, Patient Medication Information: A 2023 Proposed Rule to Help Patients Understand Their Prescription Medication Information, CDER Conversations, US Food & Drug Administration, May 2023

ePI pilot report Experience gained from creation of ePI during regulatory procedures for EU human medicines, European Medicines Agency, 2024